effectiveness of cryotherapy combined with compression therapy for preventing chemotherapy-induced peripheral neuropathy

Conditions: Breast Cancer

Summary: this is a prospective, multi-center, randomized study designed to evaluate the clinical efficacy of cryotherapy combined with compression therapy in preventing albumin-paclitaxel induced peripheral neuropathy.

all her-2 negative breast cancer patients received neoadjuvant chemotherapy with four cycles of dose-dense epirubicin and cyclophosphamide (ddec) followed by four cycles of dose-dense albumin-paclitaxel (ddt). the patients were randomly assigned in a 1:1 ratio to receive cryotherapy combined with compression or no intervention. the primary endpoint was incidence of grade 3 and higher peripheral neuropathy as assessed by nci-ctcae v5.0.

Eligibility criteria:
inclusion criteria: 1. female patients aged from 20 to 70 years old; 2. histologically confirmed as invasive breast cancer; 3. her-2 negative (defined by ihc 0 or 1+ ,or fish negative); 4. participants who meet any of the following conditions: 1) t \> 2 cm, er\ 2 cm, er≥1% and biopsy pathology (fnab or cnb) diagnosed regional lymph node metastasis; 5. without any previous treatment; 6. ddec-ddt neoadjuvant chemotherapy is planned; 7. participants must have at least one measurable disease according to recist 1.1; 8. eastern cooperative oncology group (ecog) performance status of 0 or 1; 9. lvef ≥ 50%; 10. the ecg results are judged to be almost normal or normal, or the investigator judges that the abnormalities are not clinically significant; 11. bone marrow function: absolute neutrophil counts (anc) ≥ 1.5x10\^9/l, platelets ≥ 100x10\^9/l, hemoglobin ≥ 90g/l; 12. liver and kidney function: alanine aminotransferase (alt) and aspartate aminotransferase (ast) are both ≤2.5 uln; serum total bilirubin and serum creatinine are both ≤ 1.5 uln; 13. participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form. exclusion criteria: 1. breast cancer with distant metastasis; 2. a history of other malignancies; 3. in the past or present, participants with sensory or motor neurological diseases; 4. participants who are known to be allergic to the active or other components of the study treatment; 5. cerebral thrombosis is present; 6. in the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) high-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) angina pectoris requiring anti-angina medication; 3) clinically significant valvular heart disease; 4) ecg showing transmural myocardial infarction; 5) ncontrolled hypertension (eg systolic blood pressure \> 180mm hg or diastolic blood pressure \> 100mmhg); 6) myocardial infarction; 7) congestive heart failure; 7. participants have the following serious illnesses or medical conditions, including but not limited: 1) history of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) active uncontrolled infection; 3) active pepticulcer, unstable diabetes; 8. participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation; 9. participants who were judged by the investigator to be unsuitable for this study.

Keywords: chemotherapy-induced peripheral neuropathy albumin-paclitaxel cryotherapy compression therapy dose-dense chemotherapy